Epidemiological research labelled as a violation of privacy: the case of Estonia

Since 1996, the Republic of Estonia has had data protection legislation that omits any of the exemptions for the processing of personal data for historical, statistical or scientific purposes provided by EU Directive 95/46/EC. This article describes the consequences of this legislation for public health monitoring and research. It assesses how the work of the Estonian Cancer Registry has been impaired, so that available data are now misleading, and examines the impediments that have been placed in the way of legitimate medical research. The article explains how this legislation came to be enacted and considers the reasons why this happened and why there is resistance to remedy the situation. It provides a cautionary tale about the overzealous implementation of data protection as it affects health surveillance and research.     

A cross-national comparative study of orphan drug policies in the United States, the European Union, and Japan: towards a made-in-China orphan drug policy

Rare diseases can severely impact patient life quality as well as impose a serious burden on society. But research and development for drugs to treat these disorders has stagnated because of lack of demand, insufficient knowledge of pathophysiological mechanisms, and too few patients for clinical trials. In several countries--the United States, the EU, and Japan--specific legislation has been enacted to encourage pharmaceutical companies to expedite the development of drugs for rare diseases, orphan drugs, and to assure access to them. We analyze the strengths and weaknesses of the incentives in these laws and describe the status of rare diseases in China. We offer some recommendations for orphan drug legislation in China, based on local research on rare diseases.     

Pandemic legislation in the European Union: Fit for purpose? The need for a systematic comparison of national laws

Sound governance is central to effective pandemic management. Key international legal instruments governing pandemic management in the European Union (EU): the International Health Regulations (2005) and Decision 1082/13 require EU Member States to develop national plans and invite them to establish national legal frameworks to support compliance with this international legislation. Although Member States may design the legal framework as they choose, the strongest instrument of pandemic governance is national legislation.It is currently unclear what national pandemic governance exists in Member States as it has not been mapped, i.e. identified and collated. Legal analysis and empirical evaluation of implementation and impact have therefore not been possible. We propose comprehensive mapping to create the necessary comparative data for legal analysis assessing national legislation’s compliance with international obligations and ethical principles. Empirical research could evaluate its effectiveness in promoting cross-border coherence and robust emergency response. We draw on the U.S. experience with “policy surveillance”, the systematic scientific mapping of laws of public health importance. Until national pandemic governance is mapped and evaluated, we cannot know if it is lawful, ethical or effective.     

Environmental approaches in the prevention of obesity in children and adolescents

This article aims to provide a structured review of how to create settings and environments that prevent the development of childhood overweight and obesity. It also describes which institutions and levels are responsible for environmental (global) approaches in obesity prevention and which evidence exists in terms of process and outcomes of different preventive measures. Environmental approaches in disease prevention deal with social and technical-material conditions of daily living, as those conditions significantly influence health behavior. Strategies that focus on the obesogenic environment are considered increasingly important in the prevention of obesity in children and adolescents. They can be applied at different levels (e.g., schools, communities). These interventions should aim to improve the availability of healthy foods and physical activity facilities, e.g., by provision of healthy meals and foods in schools, restaurants, and stores and by price reductions of healthy foods. Physical activity can be supported by creating attractive green spaces and playgrounds in schools and cities, improving sidewalk networks and a supportive pedestrian environment, and implementing walk-to-school projects. On a national level, policies and legislation can support changes in the social and situational environments, e.g., relating to catering in schools or TV advertisement. The practice of environmental approaches is complex, because many stakeholders from different sectors have to be involved. This may account for the observation that environmental approaches are currently underrepresented in obesity prevention.     

Policies for disease prevention in Germany in the European context: a comparative analysis

BACKGROUND: In Europe important differences exist concerning policies for the prevention of common diseases. In most cases these cannot be explained by the underlying epidemiology. However, successful policies should have a measurable effect on disease epidemiology. There has been little research comparing the effect of national preventive policies on disease-specific mortality. OBJECTIVES: To describe the mortality trends for three health problems representing the three levels of prevention in Germany and in selected European countries, which are of interest for the disease under question. To relate epidemiological trends to preventive policies at the national level and at the level of the European Union (EU). METHODS: Comparison of age-standardized mortality rates for road traffic accidents, cervical cancer and diabetes mellitus in the period 1970-2002, using routine data. Analysis of disease-specific prevention policies in countries that deviate from the general trend in the EU, with a special focus on developments in Germany. RESULTS: The development of mortality rates during the last 30 years for road traffic accidents, cervical cancer and diabetes mellitus varied substantially across Europe. Although the evidence linking specific public policies to epidemiological trends is sparse and often limited to ecological studies, a number of epidemiological changes can be plausibly linked to specific policies in the countries concerned. CONCLUSION: Successful preventive policies exist for all health problems reviewed. The current status of implementation of these policies can only be interpreted in the historical and political context of the countries concerned. The role of epidemiology to guide health policy decisions is under-utilized, as is the regulatory framework for disease and injury prevention at the level of the EU. Less formal policy measures such as European clinical guidelines are equally scarce. More rigorous comparative health services research is needed to formulate evidence-based policies for disease prevention.     

Hygiene inspections on passenger ships in Europe - an overview

Background  

Hygiene inspections on passenger ships are important for the prevention of communicable diseases. The European Union (EU) countries conduct hygiene inspections on passenger ships in order to ensure that appropriate measures have been taken to eliminate potential sources of contamination which could lead to the spread of communicable diseases. This study was implemented within the framework of the EU SHIPSAN project and it investigates the legislation applied and practices of hygiene inspections of passenger ships in the EU Member States (MS) and European Free Trade Association countries.     

Reforming the health care system: implications for health care marketers

Health care reform has become the dominant domestic policy issue in the United States. President Clinton, and the Democratic leaders in the House and Senate have all proposed legislation to reform the system. Regardless of the plan which is ultimately enacted, health care delivery will be radically changed. Health care marketers, given their perspective, have a unique opportunity to ensure their own institutions' success. Organizational, managerial, and marketing strategies can be employed to deal with the changes which will occur. Marketers can utilize personal strategies to remain proactive and successful during an era of health care reform. As outlined in this article, responding to the health care reform changes requires strategic urgency and action. However, the strategies proposed are practical regardless of the version of health care reform legislation which is ultimately enacted.     

Regulatory approaches to worker protection in nanotechnology industry in the USA and European union

A number of reports have been published regarding the applicability of existing regulatory frameworks to protect consumers and the environment from potentially adverse effects related to introduction of nanomaterials into commerce in the United States and the European Union. However, a detailed comparison of the regulatory approaches to worker safety and health in the USA and in the EU is lacking. This report aims to fill this gap by reviewing regulatory frameworks designed to protect workers and their possible application to nanotechnology.     

Need for statutory legitimation of the roles of physician's assistants

A significant constraint on new categories of health manpower is the absence of statutory legitimation of their roles. Licensure has been evolved as an effort to assure high-quality health care, but recently it has been a barrier to effective and innovative use of manpower. Medical and Nurse Practice Acts generally define the practices of medicine and nursing, but they do not define clearly the scope of these practices. Thus, these acts subject physicians to undue risks in delegating responsibilities and Type A assistants (nurses or non-nurses with special training) to undue risks in accepting those functions. Furthermore, only vague guidelines are provided to protect the public and to assure adequate quality control. To date, 35 States have enacted legislation to provide statutory legitimation of Type A assisants and to permit physicians to delegate appropriate responsibilities to new types of health manpower. It is hoped that this legislation will diminish barriers to effective use of health manpower.     

A review of legal and policy issues in legislating compensation for victims of toxic substance pollution

Despite the actual and potential effects of toxic substance pollution upon human health, the United States Congress has never enacted a comprehensive victim compensation system. The approach of the Congress, to date, has been limited by a concern about legislating on a topic fraught with scientific uncertainty--the actual causation of injury or death by toxic substance pollution. Individuals who believe they have been injured by toxic substances often bring their claims in state courts, where they face the difficult task of proving causation. Industry is principally concerned with the high cost of a compensation system, not the public health issue of scientific causation. From a policy standpoint, legislation is needed that produces information and standards on causation which assist both victims and industry. Congress has the opportunity to craft legislation that will deal rationally with an epic problem. To do so, however, the Congress must recognize scientific uncertainty as an omnipresent element of causation in cases of toxic substance pollution. This starting point, a comprehensive system of compensating victims of toxic substance pollution, can be drafted to address the values of data collection, data interpretation, prevention, conservation of economic resources, and fairness.     

Consideration of the Food Environment in Cancer Risk Reduction

Recently, there has been increased attention to the food environment's impact on chronic disease, specifically obesity and cardiovascular disease. Cancer is certainly another substantial public health concern, and dietary intake and obesity/overweight have been identified as two key cancer risk factors; however, the role of the food environment in cancer-prevention efforts seems largely uncharted territory. Previous research has shown that areas with a higher proportion of individuals in racial minority groups and areas with lower incomes have more limited access to healthful foods, which can negatively impact dietary intake and body mass index. Parallel patterns of higher cancer incidence and mortality rates among these vulnerable populations could be linked to lack of access to healthful foods. Future research utilizing food environment measures could point to broad community-level approaches for modifying diet-related cancer risk. Nutrition professionals will be a crucial element in designing and implementing food environment-based individual, family, and community interventions, which could be potent strategies for cancer prevention.     

Public Health Law and the Prevention and Control of Obesity

Context: Obesity constitutes a major public health challenge in the United States. Obesogenic environments have increased owing to the consumption of calorie-dense foods of low nutritional value and the reduction of daily physical activity (e.g., increased portion sizes of meals eaten in and out of the home and fewer physical activity requirements in schools). Policymakers and public health practitioners need to know the best practices and have the competencies to use laws and legal authorities to reverse the obesity epidemic. For instance, statutes and regulations at the federal, state, and local levels of government have been implemented to improve nutritional choices and access to healthy foods, encourage physical activity, and educate consumers about adopting healthy lifestyles.Methods: In an effort to understand the application of laws and legal authorities for obesity prevention and control, in June 2008 the Centers for Disease Control and Prevention convened the National Summit on Legal Preparedness for Obesity Prevention and Control. An outcome of this summit will be the publication of the proceeding''s white papers written by eight law and subject-matter experts with substantive contributions from summit participants, which will identify actionable options that sectors and organizations at various jurisdictional levels can consider adopting.Findings: Law has played a critical role in the control of chronic diseases and the behaviors that lead to them. The use of a systematic legal framework—the use of legislation, regulation, and policy to address the multiple factors that contribute to obesogenic environments—can assist in the development, implementation, and evaluation of a variety of legal approaches for obesity prevention and control.Conclusions: Although public health–focused legal interventions are in an early stage and the direct and indirect impact they may have on the obesity epidemic is not yet understood, efforts such as the summit and white papers should help determine potentially viable legal interventions and assess their impact on population-level change.     

Food fight: the battle over redefining competitive foods

BACKGROUND: Environmental and policy influences are potentially the most powerful-and yet the least understood-strategies for reversing the current childhood obesity epidemic. METHODS: This essay focuses on the school lunch environment and examines the key legal and policy factors that affect competitive foods or foods of minimal nutritional value (FMNV) in schools. The essay also analyzes the latest, proposed federal legislation on redefining competitive foods. RESULTS: FMNV compete for children's coins and calories in the school food environment. The emerging scientific record on the negative impact competitive foods have on children's diet and health is significantly stronger than when Congress and the United States Department of Agriculture (USDA) secretary first deemed the connection sufficient to take action. The Child Nutrition Promotion and School Lunch Protection Act of 2006, if enacted, will provide additional authority to the USDA and supply science-based federal guidance to local schools. Opposition to this legislation may come from the local school districts, the food industry, parents, and children. CONCLUSIONS: Defining competitive foods in a federally consistent manner and eliminating competitive foods from our nation's schools are food fight that will evidently be fought by legislative efforts at the local, state, and federal level. The food industry, as history illustrates, will likely work hard to weaken any regulatory efforts and could potentially demand that this fight end up requiring judicial review.     

Legislation and regulations addressing workplace violence in the United States and British Columbia

OVERVIEW: For as long as workers have had contact with customers, coworkers, the public, and others, they have faced risk of assault. However, in the 1980s and 1990s, a number of highly publicized incidents occurred that involved multiple fatalities, and reliable statistics showed homicide to be a major cause of worker deaths. As a result, violence in the workplace became a subject of concern among the public and policymakers. This article reviews a number of legislative and regulatory efforts from the past decade that were designed to prevent violence against employees. Some states and localities have enacted legislation to address specific types of violence in the workplace, such as robbery-related violence, and violence against health care workers and taxi drivers. In addition, the U.S. Occupational Safety and Health Administration (OSHA), as well as a number of state OSHA programs, has attempted to reduce the risk of assault to workers through new and existing statutes and administrative regulations. To provide a contrast with developments in the United States, the author will also discuss requirements for prevention of assault in the workplace in the Canadian province of British Columbia.     

Pathways to obesity prevention: report of a National Institutes of Health workshop

There is an extensive research base on obesity treatment and on the health benefits of weight loss, but relatively little research has focused on obesity prevention. This article summarizes results of a workshop conducted by investigators funded under a National Institutes of Health initiative designed to stimulate novel research for obesity prevention. The 20 pilot studies funded under this initiative involved study populations that were diverse with respect to life stage and ethnicity, were conducted in a variety of natural and research settings, and involved a mix of interventions, including face-to-face group and individual counseling, as well as mail, telephone, and internet-based approaches. The workshop, which occurred approximately halfway through the 3-year funding period, emphasized concepts and experiences related to initiating and conducting obesity prevention studies. Investigators discussed theoretical perspectives as well as various challenges encountered, for example, in study implementation in different clinical and community settings, in working with children and families, and in studying pregnant and postpartum women. Other topics discussed included the difficulty of motivating individuals for prevention of weight gain, relevant cultural and racial/ethnic considerations, and the particular need for valid and practical measures of energy balance, body composition, and physical fitness in obesity prevention research. A key conclusion was that using obesity treatment as the primary paradigm may be a limiting perspective for considering obesity prevention issues. Further insights derived from the workshop deliberations are reflected in a detailed list of recommendations for future obesity prevention research.     

欧美医疗器械管理经验及对中国医疗器械法规体系改革的启示

飞速发展的医疗器械提高了无数人的生活质量或挽救了他们的生命，但同时医疗器械不良事件日益增多，各国政府对此都十分重视。我国于2000年颁布了“医疗器械监督管理条例”，开始实行医疗器械市场准入制度．这在很大程度上提高了产品的安全性和有效性．但由于缺乏对上市后和使用中的医疗器械的有效监管．大量的假冒伪劣产品仍然存在。因此．改进现行的医疗器械管理体系．成了当务这急。一些发达国家，如美国和欧盟，有数十年对安全、风险变化的研究，已经建立了一个相对完善的医疗器械管理体系。分析了欧盟、美国和中国的医疗器械法规体系，包括医疗器械监督管理法规的实质性要求及其实际执行．介绍了欧美的管理经验．目的是希望对我国的医疗器械管理体系改革有所启示。     

Disease Management and the Application of Privacy Guidelines

Today, privacy is a concern for many individuals. The United States has followed the path of other countries in strengthening the legislation to protect privacy. The Health Insurance Portability and Accountability Act (HIPAA) of 1996 was enacted to provide improved portability of health benefits and greater accountability in the area of healthcare fraud. The legislation is divided into five titles with title II addressing the prevention of healthcare fraud and abuse, and the promotion of administrative simplification and privacy. The far-reaching impact of the legislation will affect hospitals, payors and physicians’ practices in every area of healthcare. HIPAA specifically governs (and identifies) all healthcare providers and payors, and clearinghouses maintain individually identifiable patient information. This legislation was in response to requested improvements including greater privacy of health information. The legislation defined some parameters but many areas remained undefined. Through the lack of definition, disease management entities were tasked with making assumptions as to the interpretation of the legislation. One of the areas that was difficult to determine was disease management. To provide more specificity, the Disease Management Association of America (DMAA) had repeatedly met with the Department of Health and Human Services to understand the intent and purpose behind the legislation.At the time of this article, the Department of Health and Human Services are collecting comments on the legislation and have already provided some updated information. The DMAA provided input to the Department of Health and Human Services regarding the application of HIPAA to disease management. The article addresses the new legislation and addresses how a disease management organization can apply the new legislation to its operation.     

Stress management in European countries and US]

In recent years, job stress and stress management have emerged as key issues in health promotion in the workplace in all of the post-industrialized countries. In the EU, the European Survey on Working Conditions has reveals that stress and musculo-skeletal disorders are the main health risks at work. In the US, NORA (national occupational research agenda) identifies 21 research priorities, in which "organization of work" is included as a job stress related factor. In this paper, trends and characteristics in occupational stress management in western countries, especially in the EU are overviewed. Presently, most stress management activities are oriented towards secondary or tertiary prevention, and are worker-oriented. But in future, priority strategy for intervention should be primary prevention, and focused on the organization as the generator of risk. In the group of countries paying a lot of attention to work stress, health policies or legal framework at the national level and a variety of activities for stress prevention at the company level are well integrated. By analyzing various stress management cases or projects, key factors for a successful approach to stress prevention are extracted as follows: 1. A stepwise and systematic approach, 2. clear determination of aims, tasks, responsibilities, planning and financial means, 3. An adequate diagnosis of risk analysis, 4. A combination of work-directed and worker-directed measures, 5. A participative approach, 6. Top management support. Costs-benefit assessment should be introduced to evaluate the effectiveness of stress prevention and to promote more integrated approaches in the workplace.     

A Legal Primer for the Obesity Prevention Movement

Public health advocates and scientists working on obesity prevention policy face challenges in balancing legal rights, individual freedom, and societal health goals. In particular, the US Constitution and the 50 state constitutions place limits on the ability of government to act, even in the best interests of the public. To help policymakers avoid crossing constitutional boundaries, we distilled the legal concepts most relevant to formulating policies aimed at preventing obesity: police power; allocation of power among federal, state, and local governments; freedom of speech; property rights; privacy; equal protection; and contract rights. The goal is to allow policymakers to avoid potential constitutional problems in the formation of obesity prevention policy.The epidemic of obesity besetting the United States is familiar—perhaps all too familiar—to the public health community. In recent years, the crisis has galvanized researchers and advocates into wide-ranging efforts to address a problem that, as the surgeon general has observed, “may soon cause as much preventable disease and death as cigarette smoking.”¹Many of these proposed solutions involve legislative or regulatory efforts by government at the federal, state, and, especially, local levels. Advocates are keenly aware of the political obstacles that they face in attempting to persuade Congress, state legislatures, city councils, or school boards to enact policies addressing the obesity epidemic. However, they may be less familiar with the legal issues involved in trying to pass a new law, promulgate a new regulation, or enforce a new policy. That lack of familiarity may result in serious problems, including the passage of legislation that is unconstitutional and the resulting costs of defending the law in court and possibly paying the attorneys'' fees of those who successfully challenge it.Many of those individuals proposing ideas to legislatures or agencies have heard lawyers use such ominous words as federal preemption and commercial speech but have had no ready way of determining what these terms might actually mean for their projects. More broadly, the obesity prevention movement lacks a concise reference guide setting out the basic legal concepts that are likely to arise in the pursuit of policy change. This primer is an attempt to address that need.